\n\u201cIn 2024, we made significant progress toward our goal of transforming the mental health treatment landscape,\u201d said Doug Drysdale, Chief Executive Officer of Cybin. \u201cOur clinical pipeline of tryptamine serotonin receptor agonists \u2013 notably CYB003, our proprietary deuterated psilocin program in development for the adjunctive treatment of MDD, and CYB004, our deuterated dimethyltryptamine, in intramuscular (\u201cIM\u201d) form being developed for the treatment of GAD – achieved several critical benchmarks.\u201d<\/p>\n
\n\u201cIt\u2019s noteworthy that in March 2024, CYB003 received FDA Breakthrough Therapy Designation. Among its many benefits, this designation provides an expedited review pathway and the potential to accelerate drug development timelines. It also includes all \u201cfast track\u201d program features and acknowledges the significant unmet medical need for more effective treatments of MDD. This is especially gratifying in light of our Phase 2 study results of CYB003 in MDD, which showed remarkable efficacy at 12 months, including a 100% response rate and a 71% remission rate among participants who received two 16 mg doses. With these outstanding findings in hand, we initiated PARADIGM\u2122, our multinational pivotal Phase 3 program, evaluating CYB003 in MDD patients. We also commenced our Phase 2 proof-of-concept study of CYB004 in GAD. I\u2019m proud of our Research and Development team and the tremendous progress made in a relatively short amount of time.\u201d<\/p>\n
\n\u201cLooking ahead, we are excited about Cybin\u2019s next phase of investigation and growth and for the upcoming milestones, including a readout of topline efficacy data from our CYB004 Phase 2 GAD study in the first quarter of 2025 and the initiation of the EXTEND and EMBRACE components of our Phase 3 PARADIGM program,\u201d concluded Drysdale.<\/p>\n
2024 Highlights:<\/b><\/p>\n
CYB003<\/b><\/p>\n CYB004<\/b><\/p>\n Presented two posters at the American College of Neuropsychopharmacology (\u201cACNP\u201d) Meeting. <\/b>The data presented include 12-month efficacy results from the Company\u2019s Phase 2 study of CYB003, its deuterated psilocin program, in MDD, which showed durable response and remission rates at 12 months, in addition to results from a completed Phase 1b study exploring drug-drug interactions between N,N-dimethyltryptamine (\u201cDMT\u201d) and selective serotonin reuptake inhibitors (\u201cSSRIs\u201d), in MDD patients.<\/p>\n CYB005<\/b><\/p>\n First-Half 2025 Expected Milestones<\/b><\/p>\n About Cybin<\/b><\/p>\n \nCybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions.<\/p>\n \nWith industry leading proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds.<\/p>\n \nFounded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For Company updates and to learn more about Cybin, visit www.cybin.com<\/a> or follow the team on X, LinkedIn, YouTube and Instagram.<\/p>\n Cautionary Notes and Forward-Looking Statements<\/b><\/p>\n \nCertain statements in this news release relating to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as \u201cmay\u201d, \u201cshould\u201d, \u201ccould\u201d, \u201cpotential\u201d, \u201cpossible\u201d, \u201cintend\u201d, \u201cestimate\u201d, \u201cplan\u201d, \u201canticipate\u201d, \u201cexpect\u201d, \u201cbelieve\u201d or \u201ccontinue\u201d, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company\u2019s plans to report Phase 2 topline results for CYB004 in Q1 2025; timing of the initiation and ability of the Company to enroll participants for the PARADIGM program; the potential for BTD to accelerate drug development timelines; and the Company\u2019s plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.<\/p>\n \nThese forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; implications of disease outbreaks on the Company’s operations; and the risk factors set out in each of the Company’s management’s discussion and analysis for the three and six month ended September 30, 2024 and the Company\u2019s annual information form for the year ended March 31, 2024, which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca<\/a> and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov<\/a>. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.<\/p>\n \nCybin makes no medical, treatment or health benefit claims about Cybin\u2019s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin\u2019s performance and operations.<\/p>\n Neither Cboe Canada, nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.<\/i><\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20250113186119\/en\/<\/a><\/span><\/p>\n Investor & Media Contact: KEYWORDS:<\/b> North America Canada<\/p>\n INDUSTRY KEYWORDS:<\/b> Mental Health Health Neurology Clinical Trials Pharmaceutical Biotechnology<\/p>\n\n
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Gabriel Fahel
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Chief Legal Officer
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Cybin Inc.
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1-866-292-4601
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irteam@cybin.com<\/a> \u2013 or \u2013 media@cybin.com<\/a><\/p>\n
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